Evaluation of COSMOsensor Glucose Monitoring System / 대한진단검사의학회지

ABSTRACT

BACKGROUND: Glucometer is a most widely-used point-of-care testing (POCT) analyzer and plays an important role in diabetes management. We evaluated the performance of the recently developed glucometer, COSMOsensor (Cosmogenome Inc., Seoul, Korea), comparing it with three foreign-made glucometers. METHODS: COSMOsensor was evaluated for linearity, precision, comparison of method and analysing time as well as the effect of operator. Other glucometers, Accu-Chek inform (Roche Diagnostics LTD., Mannheim, Germany), Precision(TM)PCx (Abbott Laboratories, Bedford, MA, USA), and Sure- Step.Flexx (LifeScan Inc., Milpitas, CA, USA) were evaluated for the same categories according to NCCLS guidelines. RESULTS: All four glucometers showed a good linearity (r> or =0.9814) and the within-run and total-run coefficients of variation (CVs) were within 3.5%. A high correlation (r> or =0.9659) was also found between the glucometers and Hitachi 7600 (Hitachi Co., Tokyo, Japan) in the central laboratory. Although differences with the reference method were within an allowable range, all glucometers showed variable bias compared with the reference method. CONCLUSIONS: The COSMOsensor showed a good analytical performance in linearity, precision, and correlation with the reference method, when compared with other foreign-made glucometers. Its rapid turnaround time and easy operation are appropriate for diabetes management and a rapid POCT analyzer. All glucometers showed variable biases, which might be due to different calibration status.